Commercialization is one of the hottest topics of discussion in the biosimilar industry, perhaps because, so far, the path to commercial success is far from black and white.
In August 2016, India’s Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology revised the September 2012 Guideline for Similar Biologics. The revision was done to keep pace with ever changing global standards and to streamline the regulatory process for the authorization of biosimilars in India. What do biosimilar makers need to know?
Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.
As the U.S. faces its first biosimilars for oncology, rheumatology, dermatology, and gastroenterology indications, a new publication from the Biosimilars Forum shows there’s quite a bit of work to be done to educate U.S. physicians.
As pharmaceutical manufacturers continue to implement serialization capabilities, there is often a failure to recognize key stakeholders within the organization who will require access to serial number data. For some organizational roles, access to serialization data will be needed on a routine basis to perform on-going activities, while for other roles the need may be required as part of an unplanned event, such as a recall, product complaint, or inquiry. To date, the majority of attention for defining requirements and qualifying solutions has resided with the serialization program/project team and has been concentrated on the data exchange between manufacturer and contract manufacturer enterprise systems and between enterprise systems and packaging site/line systems.
In 2015 and 2016, six major international regulatory authorities published guidance documents addressing data management and data integrity. Two of the guidances — the draft guidance published by the U.S. Food and Drug Administration (FDA) in April 2016 and the guidance posted by the European Medicines Agency (EMA) in August 2016, take a question and answer approach.
The FDA's John Jenkins shares several reasons why biosimilar makers shouldn't let their eagerness to get to market drive their development program.
In FDA-regulated industries, root cause analysis (RCA) is perhaps the most frequently used tool for identifying the source of a good manufacturing practice (GMP) deviation and determining an appropriate corrective and preventive action (CAPA). Yet, inadequate RCA is also one of the most common citations found in observations issued by FDA and other international regulatory bodies.
Once a process is identified as “risky,” we tend to accept that risk and do little to try to uncover ways to reduce that risk and improve the process.
During my time covering biosimilars, I’ve grown well-versed in some of these arguments, including those around naming, labeling, and reimbursement. But several discussions in the past few months have added new layers of complexity to these issues.
Pharmaceutical companies looking to take a piece of the biologics pie must come up with innovative ways to approach drug development and cut the high costs associated with it. One way to do this is to simplify the processes to produce and purify recombinant proteins. Yasuhiro Takenaka, senior director of technical development at Althea, explains how the Corynex® Protein Expression System uses an extensive toolbox to improve the levels of protein secretion and overall success rate.
The in vitro diagnostics (IVD) market is commonly segmented by techniques, products, application, end users, and geography. To better navigate the IVD diagnostic market landscape, understanding and recognizing how each segment is distinct, yet related to one another is critical for the company that wants to optimize its opportunities within this market.
The intricacy of emerging diagnostic consumables necessitates manufacturing competencies that span a wide range of disciplines. As diagnostic companies continue to develop complex consumables, the need for a strong relationship with a consumable diagnostics CMO specializing in everything from early product design to final product manufacturing will become increasingly more important.
Microfluidic Point-of-Care device technology is intersecting multiple disciplines such as materials science, systems engineering, physics, chemistry and biology. The design and manufacturing of such products require a comprehensive array of abilities, and these technologies funneled into compact devices offer an exciting foundation for innovation.
Developers of diagnostics devices are faced with the ever-increasing challenge of balancing the drive to create technologically advanced products with the pressures of today’s thrifty healthcare consumers. During the innovation process, the question often arises as to what level of regulation a diagnostic product needs to be designed, manufactured, and tested to. This article provides a brief overview of the requirements and considerations for the clinical diagnostic innovations.
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